JP4579684B2 - Aperture introducer device - Google Patents

Aperture introducer device Download PDF

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JP4579684B2
JP4579684B2 JP2004527715A JP2004527715A JP4579684B2 JP 4579684 B2 JP4579684 B2 JP 4579684B2 JP 2004527715 A JP2004527715 A JP 2004527715A JP 2004527715 A JP2004527715 A JP 2004527715A JP 4579684 B2 JP4579684 B2 JP 4579684B2
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opening
tubular member
introducer device
distal end
diameter
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JP2005534449A (en
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ホイットマン，マイケル，ピー．
ドロス，ジェラルド
ヒル，ジェレミー
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パワー メディカル インターベンションズ， エルエルシー
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs

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  • Life Sciences & Earth Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Fluid-Damping Devices (AREA)
  • Dowels (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

An orifice introducer device for introducing, for example a surgical device, into, for example an orifice of a body, includes a tubular member having a distal end and a proximal end. The distal end is adjustable between a first position for insertion into an orifice and a second position once inserted into the orifice. Alternatively, the orifice introducer device includes a distal portion having a proximal end configured to be detachably secured to the distal end of the tubular member. The distal portion is selectively detachable when the orifice introducer device is positioned in the orifice.

Description

本出願は、本明細書において参照によってその全文が明確に組み込まれる、2002年７月31日出願の米国仮特許出願第60/400,023号明細書の米国特許法（35U.S.C.）119条（e）に基づく利益を請求する。   This application is hereby incorporated by reference in its entirety and is hereby incorporated by reference in its entirety, US Provisional Patent Application No. 60 / 400,023, filed July 31, 2002, 35 U.S. C. 119 (e ) To claim profits.

本発明は、開口部導入器（orifice introducer）デバイスに関し、かつより詳しくは、例えば、外科用デバイスを身体開口部へ導入するための開口部導入器デバイスに関する。   The present invention relates to an orifice introducer device and, more particularly, to an opening introducer device, for example, for introducing a surgical device into a body opening.

外科用器具が身体開口部へ導入されるべき多くの外科手術がある。その一例が、患者の口腔または肛門腔を経由して円形のステープリング器具の導入、例えば、挿入によって胃腸管から癌または異常組織を切除する外科手術である。   There are many surgical procedures where surgical instruments are to be introduced into the body opening. One example is surgery to remove cancer or abnormal tissue from the gastrointestinal tract by introduction, eg, insertion, of a circular stapling instrument through the patient's oral cavity or anal cavity.

このタイプの外科手術中に経験される問題の１つは、身体開口部が、外科用器具がその開口部へ導入されているとき、または導入されたときに損傷されうるということである。これは、外科用デバイスが導入されている開口部が、接触に際して容易に損傷される脆弱な組織、例えば、口腔の組織を含む場合に特に問題となる。このタイプの外科手術中に経験される別の問題は、外科用器具が開口部へ導入されているとき、または導入されたときに損傷されうることである。外科用デバイスへの損傷を回避することが特に重要であるとみられるが、それは外科用デバイスが不適切に機能する場合は、患者にも危害がもたらされうるためである。   One problem experienced during this type of surgery is that the body opening can be damaged when or when a surgical instrument is introduced into the opening. This is particularly problematic when the opening into which the surgical device is introduced contains fragile tissue that is easily damaged upon contact, such as oral tissue. Another problem experienced during this type of surgery is that the surgical instrument is being introduced into the opening or can be damaged when introduced. It appears that it is particularly important to avoid damage to the surgical device because it can also be harmful to the patient if the surgical device functions improperly.

外科用器具の小型化における顕著な進歩がなされているが、外科医用器具が導入されることを必要とする開口部のサイズとほぼ同じ大きさ、それと同じ大きさ、またはそれよりも大きい多くの外科用器具が依然として存在する。開口部または外科用デバイスのいずれかに損傷を与える可能性は、外科用デバイスのサイズが、外科医用器具が導入される必要がある開口部のサイズと比べて増大するにつれて増大しうるため、従来の外科用デバイスおよび手術は依然として、外科用デバイスおよび開口部の１つまたは両方への損傷の危険を冒す。   Significant progress has been made in the miniaturization of surgical instruments, but there are many that are approximately the same size, the same size as, or larger than the size of the opening that requires the surgical instrument to be introduced. Surgical instruments still exist. The potential for damaging either the opening or the surgical device is conventional because the size of the surgical device can increase as it increases relative to the size of the opening where the surgical instrument needs to be introduced. Surgical devices and surgeries still run the risk of damage to one or both of the surgical device and the opening.

したがって、外科用デバイスが開口部へ導入されるときに外科用デバイスおよび開口部の１つまたは両方への損傷の可能性を最小限に抑えるデバイスの必要がある。   Accordingly, there is a need for a device that minimizes the possibility of damage to one or both of the surgical device and the opening when the surgical device is introduced into the opening.

本発明は、その種々の実施形態によれば、例えば、外科用デバイスを、例えば、身体開口部へ導入するための開口部導入器デバイスに関する。開口部導入器デバイスは、末端と近接端とを有する管状部材を含む。末端は、開口部へ挿入されると、開口部への挿入のための第１の位置と第２の位置との間で調節可能である。あるいは、開口部導入器デバイスは、管状部材の末端に着脱自在に固定されるように構成された近接端を有する末端部分を含む。末端部分は、開口部導入器デバイスが開口部に位置しているときに選択的に着脱自在である。   The present invention, according to its various embodiments, relates to an opening introducer device, for example, for introducing a surgical device into a body opening, for example. The opening introducer device includes a tubular member having a distal end and a proximal end. When inserted into the opening, the distal end is adjustable between a first position and a second position for insertion into the opening. Alternatively, the aperture introducer device includes a distal portion having a proximal end configured to be removably secured to the distal end of the tubular member. The distal portion is selectively removable when the opening introducer device is located in the opening.

本発明の別の例示的実施形態においては、導入器は管状シースを含む。シースの近接端の直径は、シースの末端の直径よりも大きい。例えば、シースは、略円錐状または先細の末端を有しうる。末端の直径は、その直径が末端の直径よりも大きい外科用器具の通過を可能にするように拡張可能でありうる。末端は、例えば、直径の拡張を可能にするためのスリット、縫い目（seam）、または弱い部分を含みうる。代わりとして、または追加として、末端は、伸縮性材料、例えば、近接端の直径の拡張を可能にするエラストマー材料で形成されうる。   In another exemplary embodiment of the invention, the introducer includes a tubular sheath. The diameter of the proximal end of the sheath is larger than the diameter of the distal end of the sheath. For example, the sheath can have a generally conical or tapered end. The distal diameter may be expandable to allow passage of surgical instruments whose diameter is greater than the distal diameter. The ends may include, for example, slits, seams, or weak portions to allow for diameter expansion. Alternatively or additionally, the ends may be formed of a stretchable material, for example, an elastomeric material that allows for expansion of the proximal end diameter.

本発明の別の例示的実施形態においては、導入器は、シースと末端キャプ状部（例えば、ノーズコーン）を含む。末端キャップ状部は、シースに可撤性に取付けられる。キャップ状部は、シースから除去され、シースを通じて離脱または回収されうる。   In another exemplary embodiment of the invention, the introducer includes a sheath and an end cap (eg, a nose cone). The end cap is removably attached to the sheath. The cap can be removed from the sheath and removed or collected through the sheath.

本発明は、その種々の実施形態によれば、例えば、外科用デバイスを、身体開口部、例えば、口腔へ、例えば、導入または挿入するために使用されうる開口部導入器デバイスに関する。例示のためにのみ、本発明は以下、外科用デバイスを身体開口部へ導入または挿入するために使用される開口部導入器デバイスに関連して述べられる。しかし、本発明は、その他の実施形態に従って、いかなるものでも、例えば、外科医の手、移植可能な医療デバイス等を身体開口部へ導入または挿入するためにも使用されうることが認められるべきである。追加として、または代わりとして、本発明は、その他の実施形態に従って、例えば、外科医が、その中に何かを導入または挿入することなく開口部の内側を外部から見ることを可能にするために何かを身体開口部へ導入または挿入する以外の目的に身体開口部の形状を拡張または別の方法で変更するためにも使用されることが認められるべきである。さらに、本発明は、その他の実施形態に従って、身体開口部だけではなく、いかなるタイプの開口部へも要素を導入または挿入するためにも使用されうることが認められるべきである。   The present invention, according to its various embodiments, relates to an opening introducer device that can be used, for example, to introduce or insert a surgical device into a body opening, eg, the oral cavity. For purposes of illustration only, the present invention is described below in connection with an opening introducer device that is used to introduce or insert a surgical device into a body opening. However, it should be appreciated that the present invention can be used in accordance with other embodiments to introduce or insert anything, such as a surgeon's hand, an implantable medical device, or the like, into a body opening. . In addition or alternatively, the present invention is not limited to other embodiments, for example to allow a surgeon to view the inside of an opening from the outside without introducing or inserting anything therein. It should be appreciated that it may also be used to expand or otherwise change the shape of the body opening for purposes other than introducing or inserting it into the body opening. Furthermore, it should be appreciated that the present invention can be used to introduce or insert elements into any type of opening, not just body openings, according to other embodiments.

有利に、本発明に開口部導入器デバイスは、外科用器具が、開口部へ導入または挿入されているとき、または導入または挿入されたときに身体開口部または外科用器具のいずれかに対する損傷を阻止するために機能しうる。追加として、または代わりとして、開口部導入器デバイスは、開口部を損傷することなく、比較的大きな直径を有する外科用器具が、比較的小さな直径を有する開口部を通過しうるように機能しうる。好ましくは、開口部導入器デバイスは、第１の位置または配置を有するが、ここで開口部導入器デバイスが開口部へ容易に挿入されるように構成されている。また、開口部導入器デバイスは、第２の位置または配置に調節可能であり、開口部導入器デバイスは、大きめの外科用デバイスがその中に挿入され、位置づけられうるように、例えば、開口部の形状を維持し、伸縮し、またはその他の方法で変更することによって、それを通じて例えば、大きめの外科用器具を収容し得る。好ましくは、開口部導入器デバイスは、滅菌可能であるように構成され、２回以上使用されることを可能にする。   Advantageously, the opening introducer device according to the present invention provides damage to either the body opening or the surgical instrument when the surgical instrument is introduced or inserted into the opening, or when introduced or inserted. Can function to stop. Additionally or alternatively, the aperture introducer device can function to allow a surgical instrument having a relatively large diameter to pass through an aperture having a relatively small diameter without damaging the aperture. . Preferably, the opening introducer device has a first position or arrangement, wherein the opening introducer device is configured to be easily inserted into the opening. The opening introducer device can also be adjusted to a second position or arrangement, such that the opening introducer device can be inserted and positioned within, for example, the opening introducer device. For example, a larger surgical instrument may be accommodated therethrough by maintaining the shape of the device, stretching, or otherwise changing. Preferably, the aperture introducer device is configured to be sterilizable, allowing it to be used more than once.

図１Ａおよび１Ｂは、本発明の例示的実施形態に従って、それぞれ第１の位置および第２の位置において、外科用デバイスを身体開口部へ導入するために適した開口部導入器デバイス100を示す。この実施形態においては、開口部導入器デバイス100は、略管状部材１を含む。管状部材１は、近接端１ａおよび末端１ｂを有する。末端１ｂの直径は、第１の位置において、近接端１ａの直径よりも小さい。この実施形態においては、末端１ｂは、第１の位置において略円錐状または先細である。さらに、末端１ｂは、示されている実施形態においては、長手方向のスリット２を含む。   1A and 1B show an opening introducer device 100 suitable for introducing a surgical device into a body opening in a first position and a second position, respectively, according to an exemplary embodiment of the present invention. In this embodiment, the aperture introducer device 100 includes a generally tubular member 1. The tubular member 1 has a proximal end 1a and a distal end 1b. The diameter of the end 1b is smaller than the diameter of the proximate end 1a in the first position. In this embodiment, the distal end 1b is generally conical or tapered in the first position. Furthermore, the end 1b includes a longitudinal slit 2 in the embodiment shown.

図１Ｂは、末端１ｂの調節可能性を示す。より具体的には、図１Ｂは、第２の位置において、末端１ｂが調節され、末端１ｂの直径が、第１の位置における末端１ｂの直径と比べて、増大、例えば、拡大するようになっていることを示す。例えば、末端１ｂの内径は拡大し、外科用デバイス、例えば、第１の位置において末端１ｂの直径よりも大きい直径を有する外科用デバイスが、その中を通過することを可能にする。この実施形態においては、末端１ｂは、長手方向のスリット２の開放によって調節可能である。   FIG. 1B shows the adjustability of terminal 1b. More specifically, FIG. 1B shows that, in the second position, the end 1b is adjusted such that the diameter of the end 1b increases, eg, expands, compared to the diameter of the end 1b in the first position. Indicates that For example, the inner diameter of the distal end 1b is enlarged, allowing a surgical device, eg, a surgical device having a diameter greater than the diameter of the distal end 1b in the first position, to pass therethrough. In this embodiment, the end 1b can be adjusted by opening the slit 2 in the longitudinal direction.

操作時、管状部材１の末端１ｂは、開口部へ導入され、開口部内の所望位置に達するまで末端方向へ前進される。末端１ｂでの比較的小さな直径は、開口部導入器デバイス100が開口部へより容易に導入され、前進されることを可能にする。好ましくは、開口部導入器デバイス100が所望の位置に位置していると、管状部材１の近接端１ａは開口部の外側にとどまる。次いで、滅菌可能である外科用器具が管状部材１へ挿入され、それを通じて末端に前進されうる。外科用器具としては、例えば、電気機械ドライバーの可撓軸に取り付けられる外科用器具を挙げることができるが、それらは例えば、1999年６月２日出願の「吻合、ステープリング、および切除器具と使用するための電気機械ドライバーデバイス（Electromechanical Driver Device For Use With Anastomosing, Stapling, and Resecting Instruments）」と称する米国特許第6,443,973号明細書、2000年２月22日出願の「コンピュータ支援制御機能を有する電気機械ドライバーおよび遠隔外科用器具アタッチメント（An Electromechanical Driver And Remote Surgical Instruments Attachments Having Computer Assisted Control Capabilities）」と称する米国特許出願第09/510,927号明細書、2000年２月22日出願の「可撓軸内のステアリングワイヤのステアリング機構を制御するためのキャリッジアセンブリ（Carriage Assembly for Controlling a Steering Wire Steering Mechanism Within a Flexible Shaft）」と称する米国特許第6,517,565号明細書、「吻合、ステープリング、および切除器具の使用者のための電気機械ドライバーデバイスと使用するためのステープリングデバイス（Stapling Device For Use With An Electromechanical Driver Device For User With Anastomosing, Stapling, And Resecting Instruments）」と称する米国特許第6,315,184号明細書、「電気機械ドライバーデバイスと使用するためのパラレルジョーデバイス（Parallel Jaw Device For Use With An Electromechanical Driver Device）」と称する米国特許第6,264,087号明細書、「電気機械ドライバーデバイスと使用するための管腔拡張アタッチメント（Vessel And Lumen Expander Attachment For Use With An Electromechanical Driver Device）」と称する米国特許第6,348,061号明細書、2000年２月22日出願の「吻合、切除、およびステープリング器具と使用するための液体送達デバイス（Fluid Delivery Device For Use With Anastomosing, Resecting, and Stapling Instruments）」と称する米国特許第6,488,197号明細書、2000年２月22日出願の「吻合、切除、およびステープリング器具と使用するための液体送達機構（A Fluid Delivery Mechanism For Use With Anastomosing, Resecting, And Stapling Instruments）」と称する米国特許第6,491,201号明細書、2000年２月22日出願の「電気機械ドライバーデバイスと使用するための組織ステープリングアタッチメント（A Tissue Stapling Attachment For Use With An Electromechanical Driver Device）」と称する米国特許第6,533,157号明細書、2001年６月22日出願の「電気−機械外科用デバイス（Electro - Mechanical Surgical Device）」と称する米国特許出願第09/887,789号明細書、2002年３月14日出願の「トロカールデバイス（Trocar Device）」と称する米国特許出願第10/098,217号明細書、2002年４月22日出願の「バイポーラまたは超音波外科用デバイス（Bipolar Or Ultrasonic Surgical Device）」と称する米国特許出願第10/128,768号明細書、2002年４月22日出願の「イメージングデバイス（Imaging Device）」と称する米国特許出願第10/127,310号明細書、2002年１月30日出願の「外科用イメージングデバイス（Surgical Imaging Device）」と称する米国特許出願第60/352,726号明細書、2001年11月30日出願の「外科用デバイス（Surgical Device）」と称する米国特許出願第09/999,546号明細書、2002年３月８日出願の「外科用デバイス（A Surgical Device）」と称する米国特許出願第10/094,051号明細書、ならびに2002年６月14日出願の「外科用デバイス」と称する米国特許出願第60/388,644号明細書に記載されており、その各々は参照によってその全文が明確に組み込まれている。   In operation, the distal end 1b of the tubular member 1 is introduced into the opening and advanced distally until a desired position in the opening is reached. The relatively small diameter at the distal end 1b allows the opening introducer device 100 to be more easily introduced and advanced into the opening. Preferably, when the opening introducer device 100 is in the desired position, the proximal end 1a of the tubular member 1 remains outside the opening. A surgical instrument that can be sterilized can then be inserted into the tubular member 1 and advanced distally therethrough. Surgical instruments can include, for example, surgical instruments that are attached to the flexible shaft of an electromechanical driver, such as the “anastomosis, stapling, and resection instruments” filed June 2, 1999. US Pat. No. 6,443,973, entitled “Electromechanical Driver Device For Use With Anastomosing, Stapling, and Resecting Instruments”, filed Feb. 22, 2000, “Electric with Computer Aided Control Function” US patent application Ser. No. 09 / 510,927, filed Feb. 22, 2000, entitled “An Electromechanical Driver And Remote Surgical Instruments Attachments Having Computer Assisted Control Capabilities”. Carriage Assembly for controlling steering mechanism of steering wire US Pat. No. 6,517,565, “Controlling a Steering Wire Steering Mechanism Within a Flexible Shaft”, “A stapling device for use with an electromechanical driver device for users of anastomosis, stapling, and ablation instruments” U.S. Pat. No. 6,315,184 entitled "Stapling Device For Use With An Electromechanical Driver Device For User With Anastomosing, Stapling, And Resecting Instruments", "Parallel Jaw Device For Use US Patent No. 6,264,087, entitled “With An Electromechanical Driver Device”, US Patent entitled “Vessel And Lumen Expander Attachment For Use With An Electromechanical Driver Device” No. 6,348,061, filed February 22, 2000, “Anastomosis, US Pat. No. 6,488,197 entitled “Fluid Delivery Device For Use With Anastomosing, Resecting, and Stapling Instruments”, filed Feb. 22, 2000, “Anastomosis” US Pat. No. 6,491,201, filed Feb. 22, 2000, entitled “A Fluid Delivery Mechanism For Use With Anastomosing, Resecting, And Stapling Instruments”. US Pat. No. 6,533,157 entitled “A Tissue Stapling Attachment For Use With An Electromechanical Driver Device”, filed Jun. 22, 2001 US Patent Application No. 09 / 887,789 entitled “Electro-Mechanical Surgical Device”, “Trocar” filed Mar. 14, 2002 US patent application Ser. No. 10 / 098,217 entitled “Trocar Device”, US patent application Ser. No. 10 entitled “Bipolar Or Ultrasonic Surgical Device” filed Apr. 22, 2002 US patent application Ser. No. 10 / 127,310, filed Apr. 22, 2002, entitled “Imaging Device”, filed Jan. 30, 2002, “Surgical Imaging Device (Surgical Device)” No. 60 / 352,726, entitled “Imaging Device”, US Patent Application No. 09 / 999,546, entitled “Surgical Device”, filed Nov. 30, 2001, March 2002 US patent application Ser. No. 10 / 094,051 entitled “A Surgical Device” filed on Jan. 8, and US Patent Application No. 60/96 entitled “Surgical Device” filed on June 14, 2002. 388,644 specification, Each in its entirety is hereby expressly incorporated by reference.

外科用器具が管状部材１の末端１ｂに達すると、末端１ｂの直径は、外科用器具の少なくとも一部分が、末端１ｂを通じて、入り、例えば、延びることを可能にするために、調節され、例えば、拡張されうる。末端１ｂの拡張は、例えば、管状部材１の内壁を押す外科用器具の力によってひき起こされうる。図１Ａおよび１Ｂに示されている例においては、末端１ｂは、長手方向のスリット２によって、例えば、スリット２の側面２ａおよび２ｂの分離によって拡張し、外科用器具がその中を通過するのを可能にする。   When the surgical instrument reaches the distal end 1b of the tubular member 1, the diameter of the distal end 1b is adjusted to allow at least a portion of the surgical instrument to enter, for example, extend through the distal end 1b, eg, Can be extended. The expansion of the distal end 1 b can be caused, for example, by the force of a surgical instrument that pushes the inner wall of the tubular member 1. In the example shown in FIGS. 1A and 1B, the distal end 1b is expanded by a longitudinal slit 2, for example by separating the side surfaces 2a and 2b of the slit 2, allowing the surgical instrument to pass therethrough. enable.

図１Ａ〜１Ｂの実施形態は、管状部材１の末端１ｂが、調節可能、例えば、拡張可能でありうることを示すが、管状部材１の全体が調節可能である別の配置が可能である。さらに、図１Ａ〜１Ｂの実施形態は、管状部材１の末端１ｂが、スリット２によって、調節可能、例えば、拡張可能であるが、末端１ｂに調節可能性を提供するための別の配置も可能である。例えば、管状部材１の末端１ｂは、エラストマー材料などの伸縮性材料で形成されうるが、それによって外科用器具、例えば、第１の位置において末端１ｂの直径よりも大きい直径を有する外科用器具の、管状部材１の内壁に対する力が、末端１ｂの材料を伸縮し、末端１ｂの直径を増大させ、かつ外科用器具をその中を通過させることができる。代わりとして、または追加として、管状部材１の末端１ｂは、１つもしくはそれ以上の縫い目、ミシン目（perforation）、または弱い部分を含み、これらは裂け、割れ、または別の方法で開放または伸縮し、管状部材１の末端１ｂの内径を増大させることができる。   While the embodiment of FIGS. 1A-1B shows that the distal end 1b of the tubular member 1 can be adjustable, for example, expandable, other arrangements are possible where the entire tubular member 1 is adjustable. Further, the embodiment of FIGS. 1A-1B is such that the distal end 1b of the tubular member 1 is adjustable, eg expandable, by the slit 2, but other arrangements are also possible to provide adjustability to the distal end 1b. It is. For example, the distal end 1b of the tubular member 1 can be formed of a stretchable material, such as an elastomeric material, whereby a surgical instrument, eg, a surgical instrument having a diameter larger than the diameter of the distal end 1b in the first position. The force on the inner wall of the tubular member 1 can expand and contract the material of the distal end 1b, increase the diameter of the distal end 1b, and allow the surgical instrument to pass therethrough. Alternatively or additionally, the distal end 1b of the tubular member 1 includes one or more seams, perforations, or weak portions that are torn, cracked or otherwise open or stretched. The inner diameter of the end 1b of the tubular member 1 can be increased.

図２Ａ〜２Ｄは、本発明の別の実施形態による開口部導入器デバイス200を示す。この実施形態においては、図２Ａに示されているように、開口部導入器デバイス200は、近接端21ａと末端21ｂとを有する管状部材21を含む。管状部材21の末端21ｂは、長手方向に延びるｖ状の開口またはスリット21eを含み、開口21ｅの末端が開口21ｅの近接端よりも開放位置で広くなっている。この実施形態においては、開口21ｅの側面21ｃ、21ｄの各々は、それを通じて紐22ａが通され、進められ、または固定され（corsetted）うる多くの穴22を含む。管状部材21の近接端21ａは、作動デバイス20を含む。作動デバイス20は、紐22ａを把握するためのリング（ring）25または同種のものを含みうる。   2A-2D show an aperture introducer device 200 according to another embodiment of the present invention. In this embodiment, as shown in FIG. 2A, the aperture introducer device 200 includes a tubular member 21 having a proximal end 21a and a distal end 21b. The end 21b of the tubular member 21 includes a v-shaped opening or slit 21e extending in the longitudinal direction, and the end of the opening 21e is wider at the open position than the proximal end of the opening 21e. In this embodiment, each of the side surfaces 21c, 21d of the opening 21e includes a number of holes 22 through which the string 22a can be threaded, advanced or corsetted. The proximal end 21 a of the tubular member 21 includes an actuation device 20. The actuation device 20 may include a ring 25 or the like for grasping the string 22a.

図２Ｂにさらに細部にわたって示されているように、リング25は、それを通じて紐22ａの両端が通過する穴25ａを含みうる。特に、紐22ａの第１および第２の端は、開口部導入器デバイス200の末端21ｂでの穴22内に通され、管状部材21の内側を通じて延び、それぞれ、穴23および27ａを通じて現れる。紐22ａ第１および第２の端は、クリンプ（crimp）26によって穴25ａを通じてリング25に固定される。図示されているように、穴27ａは、グロメット（grommet）27を含み、例えば、穴27ａの側面に対する紐22ａの摩擦を減少させる。 As shown in more detail in FIG. 2B, the ring 25 may include a hole 25a through which the ends of the string 22a pass. In particular, the first and second ends of the string 22a are threaded through the hole 22 at the distal end 21b of the opening introducer device 200 and extend through the inside of the tubular member 21 and emerge through holes 23 and 27a, respectively. The first and second ends of the cord 22a are secured to the ring 25 through holes 25a by crimps 26. As shown, the hole 27a includes a grommet 27, for example, to reduce the friction of the string 22a against the side of the hole 27a.

開口部導入器デバイス200の開口部への挿入前に、リング25は、近接方向へ移動、例えば、引かれ、開口21ｅの側面21ｃおよび21ｄを引き寄せ、それによって、図２Ｃに示されているように管状部材21の末端21ｂの直径を削減しうる。管状部材21の末端21ｂの削減された直径は、開口部導入器デバイス200の開口部へのより容易な挿入を可能にする。開口部導入器デバイス200が開口部へ挿入され、かつ所望の位置に位置した後、管状部材21の末端21ｂの直径は図２Ｄに示されているように増大し、外科用器具がその中を通過することを可能にしうる。管状部材21の末端21ｂの直径を増大させるためには、リング25は、反対方向、例えば、末端方向に移動され、それによって紐22ａの張りを解除することができる。   Prior to insertion of the aperture introducer device 200 into the aperture, the ring 25 is moved in a proximal direction, eg, pulled, pulling on the sides 21c and 21d of the aperture 21e, thereby as shown in FIG. 2C. In addition, the diameter of the end 21b of the tubular member 21 can be reduced. The reduced diameter of the distal end 21b of the tubular member 21 allows easier insertion into the opening of the opening introducer device 200. After the opening introducer device 200 is inserted into the opening and positioned in the desired position, the diameter of the distal end 21b of the tubular member 21 increases as shown in FIG. May be able to pass through. In order to increase the diameter of the distal end 21b of the tubular member 21, the ring 25 can be moved in the opposite direction, for example in the distal direction, thereby releasing the tension of the cord 22a.

管状部材21の末端21ｂでの穴22を通じて紐22ａを通し、かつ作動デバイス20へ紐22ａを固定するために使用される、例えば管状部材21の近接端21ａでのリング25など、多くの多数の異なる配置があることが認められるべきである。例えば、本発明の別の例示的実施形態において、クリンプ26は、穴27ａの近接側面で管状部材21へ固定されうる。紐22ａの第１および第２の端は、リング25の穴25ａを通じて延び、クリンプ26へ接続されうる。次いで、リング25は、一方向、例えば、末端方向へ移動され、管状部材21の末端21ｂの直径を減少させ、かつ反対方向、例えば、近接方向へ移動され、管状部材21の末端21ｂの直径を増大させることができる。   A number of numerous, such as a ring 25 at the proximal end 21a of the tubular member 21, is used to pass the string 22a through the hole 22 at the distal end 21b of the tubular member 21 and to secure the string 22a to the actuation device 20. It should be appreciated that there are different arrangements. For example, in another exemplary embodiment of the present invention, the crimp 26 may be secured to the tubular member 21 at the proximal side of the hole 27a. The first and second ends of the string 22a can extend through the hole 25a in the ring 25 and be connected to the crimp 26. The ring 25 is then moved in one direction, eg, the distal direction, to reduce the diameter of the distal end 21b of the tubular member 21, and moved in the opposite direction, eg, the proximal direction, to reduce the diameter of the distal end 21b of the tubular member 21. Can be increased.

図３Ａ〜３Ｇは、開口部導入器デバイス400、および本発明の別の例示的実施形態によるその使用を示す。この実施形態においては、略管状部材300は、末端部分310、例えば、ノーズコーンをその末端315に備える。管状部材300は、例えば、テフロン（登録商標）材料で形成されうる。末端部分310は、管状部材300の末端315に着脱自在に取付けられるように構成されている。末端部分30は、末端部分310の末端が末端部分310および管状部材300の近接端よりも小さな直径を有するように略円錐状または先細でありうる。末端部分310は一般に、開口部へ挿入されるようにサイズと形状が決められている。末端部分310は、開放または閉鎖された末端を有し、かつ、形状が、例えば、先細、円錐形、切頭円錐形、鈍形等でありうる。末端部分310の近接端325は、管状部材300の末端315に取付けられるために略環状でありうる。この実施形態においては、末端部分310は、少なくとも部分的に可撓性、例えば、エラストマー材料で形成されうる。末端部分310は、例えば、管状部材300の末端315の周りで伸縮されうる。追加として、または代わりとして、他の方法および／またはデバイスを用いて、末端部分310を管状部材300の末端315に取り付けることができるが、それには非限定的な例、すなわち、電気接続、接着剤、粘着性組成物、結合部材、ファスナー、管状部材の材料と分子結合する材料等が含まれる。   3A-3G illustrate an aperture introducer device 400 and its use in accordance with another exemplary embodiment of the present invention. In this embodiment, the generally tubular member 300 includes a distal portion 310, eg, a nose cone, at its distal end 315. The tubular member 300 can be formed of, for example, a Teflon (registered trademark) material. The end portion 310 is configured to be removably attached to the end 315 of the tubular member 300. End portion 30 may be generally conical or tapered such that the end of end portion 310 has a smaller diameter than end portion 310 and the proximal end of tubular member 300. The end portion 310 is generally sized and shaped to be inserted into the opening. The end portion 310 has an open or closed end and the shape can be, for example, tapered, conical, frustoconical, blunted, etc. The proximal end 325 of the distal portion 310 can be generally annular for attachment to the distal end 315 of the tubular member 300. In this embodiment, the end portion 310 can be at least partially flexible, eg, formed of an elastomeric material. The end portion 310 can be stretched around the end 315 of the tubular member 300, for example. Additionally or alternatively, other methods and / or devices can be used to attach the distal portion 310 to the distal end 315 of the tubular member 300, including but not limited to: electrical connections, adhesives , Adhesive compositions, binding members, fasteners, materials that molecularly bond with materials of tubular members, and the like.

図３Ｂは、図３Ａに示されている開口部導入器デバイス400の部分的断面図である。図３Ｂに示されているように、末端部分310の近接端325は、環状溝320を含む。環状溝320は、管状部材300の末端315を受け入れるように構成されている。図３Ｃは、環状溝320の一部分のさらに細部を示す。図３Ｃに示されているように、環状溝320は、対向する部材320ａと320ｂと間で管状部材300の末端315を摩擦抵抗により保持するために構成されている。   FIG. 3B is a partial cross-sectional view of the aperture introducer device 400 shown in FIG. 3A. As shown in FIG. 3B, the proximal end 325 of the distal portion 310 includes an annular groove 320. The annular groove 320 is configured to receive the distal end 315 of the tubular member 300. FIG. 3C shows further details of a portion of the annular groove 320. As shown in FIG. 3C, the annular groove 320 is configured to hold the distal end 315 of the tubular member 300 between the opposing members 320a and 320b by frictional resistance.

上記の通り、この実施形態においては、末端部分310は、可撓性、例えば、エラストマー材料で形成されうる。図３Ｄは、管状部材300の末端315がその中に挿入されていない場合の、図３Ｃに示されている環状溝320の一部分を示す。図３Ｄに示されているように、環状溝320が格納されている末端部分310の近接端325は、内側に曲がるために、例えば、管状部材300の末端315が環状溝320へ挿入されていないとき、減少した直径を有するために偏倚される（ｂｉａｓｅｄ）。好ましくは、末端部分310の近接端325は十分に偏倚され、管状部材300の末端315が環状溝320へ挿入されていないとき、末端部分310の内部に曲った近接端325は管状部材300の内径よりも小さい外径を有するようになっている。   As described above, in this embodiment, the distal portion 310 can be formed of a flexible, e.g., elastomeric material. FIG. 3D shows a portion of the annular groove 320 shown in FIG. 3C when the distal end 315 of the tubular member 300 is not inserted therein. As shown in FIG. 3D, the proximal end 325 of the distal portion 310 in which the annular groove 320 is retracted is bent inward, for example, so that the distal end 315 of the tubular member 300 is not inserted into the annular groove 320. Sometimes biased to have a reduced diameter. Preferably, the proximal end 325 of the distal portion 310 is sufficiently biased so that when the distal end 315 of the tubular member 300 is not inserted into the annular groove 320, the proximal end 325 bent into the interior of the distal portion 310 is the inner diameter of the tubular member 300. It has a smaller outer diameter.

図３Ｅ〜３Ｇは、本発明の１つの例示的実施形態による、図３Ａ〜３Ｄに示されている開口部導入器デバイス300の使用を示す。この実施形態におていは、開口部導入器デバイス300は管状挿入デバイス330とともに使用される。例えば、図３Ｅは、それを通じて挿入される管状挿入デバイス330を有する開口部導入器デバイス300を示す。１つの実施形態においては、管状挿入デバイス330は、テフロン（登録商標）材料で形成される。管状挿入デバイス330は、管状部材300においてスライド自在に受入れ可能であり、末端部分310の内壁311に接触するように構成されている。好ましくは、管状挿入デバイス330は十分な長さを有し、管状部材300を通じて完全に挿入されると、管状挿入デバイス330の近接端330ａが、管状部材300の近接端300ａを超えて延び、開口部の外側の外科医によって管状挿入デバイス330の操作を可能にするようになっている。 3E-3G illustrate the use of the aperture introducer device 300 shown in FIGS. 3A-3D, according to one exemplary embodiment of the present invention. Otay to this embodiment, orifice introducer device 3 00 is used with a tubular insertion device 330. For example, Figure 3E shows an orifice introducer device 3 00 having a tubular insertion device 330 is inserted therethrough. In one embodiment, the tubular insertion device 330 is formed of a Teflon material. Tubular insertion device 330 is slidably received in tubular member 300 and is configured to contact inner wall 311 of end portion 310. Preferably, the tubular insertion device 330 has a sufficient length so that when fully inserted through the tubular member 300, the proximal end 330a of the tubular insertion device 330 extends beyond the proximal end 300a of the tubular member 300 and opens. The operation of the tubular insertion device 330 is enabled by a surgeon outside the section.

図３Ｅの開口部導入器デバイスは、回収デバイス、例えば末端部分310の内壁311に固定して取付けられた紐340などをさらに含む。好ましくは、紐340の近接端340ａは、管状部材300の近接端を超えて延び、紐340が外科医によって近接方向へ張られ、かつ／または引かれうると同時に管状部材300が開口部内の位置に放置されるようになっている。   The opening introducer device of FIG. 3E further includes a retrieval device, such as a string 340 fixedly attached to the inner wall 311 of the distal portion 310. Preferably, the proximal end 340a of the string 340 extends beyond the proximal end of the tubular member 300 so that the string 340 can be tensioned and / or pulled in a proximal direction by the surgeon while the tubular member 300 is in position within the opening. It is supposed to be left unattended.

操作時、末端部分310は、例えば、環状溝320によって管状部材300上に着脱自在に取付けられている。次いで、末端部分310を含む管状部材300は、開口部へ導入される。管状部材300が適切に位置していると、管状挿入デバイス330は、管状部材300へ挿入される。あるいは、管状挿入デバイス330は、開口部の管状部材300の導入および／または位置決めの前に管状部材300へ挿入されうる。次いで、管状挿入デバイス330は、管状挿入デバイス330の末端が末端部分310の内壁311に接触するまで、末端方向へ管状部材300内を前進される。次いで、管状挿入デバイス330は、末端部分310が管状部材300の近接端300ａから取り外されるために、さらに末端に前進される。あるいは、管状部材300は近接に引き戻されると同時に、管状挿入デバイス330は適所に維持される。図３Ｆは、例えば、管状部材300から取り外された後の末端部分310を示す。   In operation, the end portion 310 is detachably mounted on the tubular member 300 by, for example, an annular groove 320. The tubular member 300 including the end portion 310 is then introduced into the opening. When the tubular member 300 is properly positioned, the tubular insertion device 330 is inserted into the tubular member 300. Alternatively, the tubular insertion device 330 can be inserted into the tubular member 300 prior to the introduction and / or positioning of the tubular member 300 in the opening. The tubular insertion device 330 is then advanced distally within the tubular member 300 until the distal end of the tubular insertion device 330 contacts the inner wall 311 of the distal portion 310. The tubular insertion device 330 is then advanced further distally so that the distal portion 310 is removed from the proximal end 300a of the tubular member 300. Alternatively, the tubular member 300 is pulled back in close proximity while the tubular insertion device 330 is maintained in place. FIG. 3F shows the distal portion 310 after it has been removed from the tubular member 300, for example.

末端部分310が管状部材300の末端315から取り外されると、末端部分310の近接端310ａは収縮しうる。有利に、末端部分310の近接端310ａは十分に収縮し、末端部分310の外径が管状部材300の内径よりも小さくなるようになっている。次いで、管状挿入デバイス330は、管状部材300に対して近接に移動させることによって管状部材300から除去されうる。さらに、収縮すると、末端部分310の外径は管状部材の内径よりも小さいため、末端部分310は紐340を近接に引くことによって管状部材300を通じて離脱されうる。その後、管状部材300は、開口部内の位置にとどまり、外科用デバイスは管状部材300の近接端へ挿入され、かつそれを通じて末端に前進されうる。   When the distal portion 310 is removed from the distal end 315 of the tubular member 300, the proximal end 310a of the distal portion 310 can contract. Advantageously, the proximal end 310 a of the distal portion 310 is sufficiently contracted so that the outer diameter of the distal portion 310 is smaller than the inner diameter of the tubular member 300. Tubular insertion device 330 can then be removed from tubular member 300 by moving it proximally relative to tubular member 300. Further, when contracted, the outer diameter of the end portion 310 is smaller than the inner diameter of the tubular member so that the end portion 310 can be detached through the tubular member 300 by pulling the string 340 closer. Thereafter, the tubular member 300 remains in position within the opening and the surgical device can be inserted into the proximal end of the tubular member 300 and advanced distally therethrough.

あるいは、本発明の１つの例示的実施形態においては、末端部分310の近接端310ａは十分に収縮し、末端部分310の外径が管状挿入デバイス330の内径よりも小さくなり、末端部分310が管状挿入デバイス330を通じて近接に離脱されうると同時に、管状挿入デバイス330を管状部材300内の適所に放置するようになっている。この実施形態においては、管状部材300および管状挿入デバイス330の両方は、開口部内の位置に放置されうるとともに、外科用デバイスはその後に管状挿入デバイス330の近接端330ａへ挿入され、かつそれを通じて末端に前進されうる。   Alternatively, in one exemplary embodiment of the present invention, the proximal end 310a of the distal portion 310 is sufficiently contracted, the outer diameter of the distal portion 310 is smaller than the inner diameter of the tubular insertion device 330, and the distal portion 310 is tubular. The tubular insertion device 330 can be left in place within the tubular member 300 while it can be removed proximately through the insertion device 330. In this embodiment, both the tubular member 300 and the tubular insertion device 330 can be left in position within the opening, and the surgical device is subsequently inserted into and proximally through the proximal end 330a of the tubular insertion device 330. Can be advanced.

本発明のいくつかの実施形態が、本明細書において具体的に示され、かつ／または述べられている。しかし、当然のことながら、本発明の変更および変形が、本発明の精神および所期の範囲から逸脱することなく上記の開示によって適用される。   Several embodiments of the present invention are specifically shown and / or described herein. However, it will be appreciated that modifications and variations of the present invention may be applied according to the above disclosure without departing from the spirit and scope of the invention.

本発明の１つの例示的実施形態による、閉鎖位置における開口部導入器デバイスを示す側面図である。FIG. 3 is a side view of an aperture introducer device in a closed position, according to one exemplary embodiment of the present invention. 開放位置における、図１Ａに示されている開口部導入器デバイスを示す側面図である。1B is a side view of the aperture introducer device shown in FIG. 1A in an open position. FIG. 本発明の別の例示的実施形態による開口部導入器デバイスを示す斜視図である。FIG. 6 is a perspective view of an aperture introducer device according to another exemplary embodiment of the present invention. 図２Ａに示されている開口部導入器デバイスの近接端のさらに細部を示す部分的斜視図である。2B is a partial perspective view showing further details of the proximal end of the aperture introducer device shown in FIG. 2A. FIG. 閉鎖における図２Ａに示されている開口部導入器デバイスの末端のさらに細部を示す部分的側面図である。2B is a partial side view showing further details of the distal end of the aperture introducer device shown in FIG. 2A in closure. FIG. 開放位置における図２Ａに示されている開口部導入器デバイスの末端のさらに細部を示す側面図である。2B is a side view showing further details of the distal end of the aperture introducer device shown in FIG. 2A in an open position. FIG. 本発明の別の例示的実施形態による開口部導入器デバイスを示す側面図である。FIG. 7 is a side view of an aperture introducer device according to another exemplary embodiment of the present invention. 図３Ａに示されている開口部導入器デバイスの部分的断面側面図である。3B is a partial cross-sectional side view of the aperture introducer device shown in FIG. 3A. FIG. 図３Ａに示されている開口部導入器デバイスの付属末端部分のさらに細部を示す部分的断面側面図である。3B is a partial cross-sectional side view showing further details of the accessory end portion of the aperture introducer device shown in FIG. 3A. FIG. 図３Ａに示されている開口部導入器デバイスの取り外された末端部分のさらに細部を示す部分的断面側面図である。3B is a partial cross-sectional side view showing further details of the detached end portion of the aperture introducer device shown in FIG. 3A. FIG. その中に挿入された第２の管状本体を有する図３Ａに示されている開口部導入器デバイスの部分的断面側面図である。3B is a partial cross-sectional side view of the aperture introducer device shown in FIG. 3A having a second tubular body inserted therein. FIG. その中にさらに挿入されている第２の管状本体を有する図３Ａに示されている開口部導入器デバイスの部分的断面側面図である。FIG. 3B is a partial cross-sectional side view of the aperture introducer device shown in FIG. 3A having a second tubular body further inserted therein. それらを通じて部分的離脱される末端部分を有する図３Ａに示されている開口部導入器デバイスの部分的断面側面図である。3B is a partial cross-sectional side view of the aperture introducer device shown in FIG. 3A having a distal portion partially disengaged therethrough. FIG.

Claims (5)

末端および近接端を有する管状部材を含んで成り、
前記末端が、開口部への挿入のための第１の位置と前記開口部へいったん挿入された第２の位置との間で調節可能であり、前記第１の位置において、前記末端が前記近接端よりも小さい直径を有し、そして前記末端の前記直径が前記第１の位置と比べ前記第２の位置においてより大きく、そして前記末端がスリットを含み、かつ前記末端の前記直径が、前記スリットの開放によって前記第１の位置に対して前記第２の位置に調節され、前記末端が、前記スリットに隣接した複数の穴と、前記穴を貫く紐とを含み、かつ前記スリットの開放が前記紐を移動させることによって制御される、開口部導入器デバイス。Comprising a tubular member having a distal end and a proximal end;
The end is adjustable between a first position for insertion into the opening and a second position once inserted into the opening, where the end is in the proximity And having a diameter smaller than an end, and the diameter of the end is larger in the second position than the first position, and the end includes a slit, and the diameter of the end is the slit The opening is adjusted to the second position relative to the first position, the end includes a plurality of holes adjacent to the slit and a string extending through the hole, and the opening of the slit is the An opening introducer device that is controlled by moving the string. 前記紐が前記紐の移動を制御するための作動デバイスに取付けられている、請求項１に記載の開口部導入器デバイス。The opening introducer device of claim 1, wherein the string is attached to an actuation device for controlling movement of the string. 前記紐の一端が作動デバイスに取付けられている、請求項１に記載の開口部導入器デバイス。The opening introducer device of claim 1, wherein one end of the string is attached to an actuation device. 前記紐の両端が作動デバイスに取付けられている、請求項１に記載の開口部導入器デバイス。The opening introducer device of claim 1, wherein both ends of the string are attached to an actuation device. 前記作動デバイスが、リングを含む、請求項２に記載の開口部導入器デバイス。The opening introducer device of claim 2, wherein the actuation device comprises a ring.
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US20040097958A1 (en) 2004-05-20
CA2722645A1 (en) 2004-02-19
CN1678245A (en) 2005-10-05
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US9554824B2 (en) 2017-01-31
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CA2494077A1 (en) 2004-02-19
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US20110082342A1 (en) 2011-04-07
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WO2004014234A2 (en) 2004-02-19
CA2494077C (en) 2011-04-12

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